Time Restricted Feeding, Muscle, and Metabolism

Obesity Clinical Trial

— TRIMM  

Official title:

Time Restricted Feeding Intervention for Muscle and Metabolic Health (TRIMM)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04949451
• Other study ID #: TRIMM062021
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2021
• Est. completion date: May 30, 2023

Study information

• Verified date: June 2021
• Source: University of Arkansas, Fayetteville
• Contact: Jamie Baum, PhD
• Phone: 479-575-4474
• Email: baum[@]uark.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Effective nutrition strategies for combatting and/or preventing obesity still need to be identified. This has been the case despite the numerous and different approaches that have been taken. Potential targets for combatting/preventing obesity have been identified, but long-term solutions have not emerged. This study uses time restricted feeding to study the role of dietary protein in obesity prevention and/or treatment. The objectives are to determine the role of skeletal muscle mass as a driver of energy-sensing mechanisms and peripheral signals that regulate appetite and energy intake in overweight and obese adults and to determine the effects of protein timing on muscle mass to regulate appetite and energy intake in overweight and obese adults.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

• Resides in Northwest Arkansas

• Age 25-50 years

• BMI > 25

• All ethnicities

• Female and male

Exclusion Criteria:

• Food allergies

• Pregnant or breastfeeding

• Dietary restrictions (e.g. vegetarian, vegan, etc.)

• Trying to lose weight in last 3 months

• Pre-existing health conditions related to obesity (e.g. cardiovascular disease, diabetes, hypertension)

• Prescription medications related to heart disease or type 2 diabetes

• Fear of needles

• Smoker or vaping

• Currently taking protein supplements or other nutritional supplements which may interfere with study outcomes

• Consumes >4 alcoholic beverages per week

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• Whey protein supplement
Participants consume whey protein at the beginning of the eating period.
• Ketogenic aid
Participants consume ketogenic aid upon waking.

Other:
• Control group - time restricted feeding only
Time restricted feeding.

Locations

Country	Name	City	State
United States	University of Arkansas	Fayetteville	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas, Fayetteville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition	Body composition measured using dual x-ray absorptiometry to determine the ration of lean/fat-free mass to fat mass.	Change is being assessed at baseline and final day (day 120) of the intervention.
Secondary	Whole body protein turnover	Whole body protein turnover will be measured using 15N-alanine	Change is being assessed at baseline and final day (day 120) of the intervention.
Secondary	Muscle mass	Muscle mass will be measured using D3-creatine	Change is being assessed at baseline and final day (day 120) of the intervention.
Secondary	Body weight	Body weight will be measured in kilograms.	Change is being assessed at baseline, 4, 8, and 12 weeks.
Secondary	Sleep	Sleep will be assessed using wrist Actigraphy for sleep duration and total time in bed.	Change is being assessed at baseline and 12 weeks
Secondary	Sleep Quality	Sleep quality will be measured using the Pittsburgh Sleep Quality Index survey	Change is being assessed at baseline, 4, 8, and 12 weeks
Secondary	Mood	Mood will be assessed using the Profile of Mood States Questionnaire	Change is being assessed at baseline, 4, 8, and 12 weeks
Secondary	Grit	Grit will be assessed using the grit questionnaire.	Change is being assessed at baseline, 4, 8, and 12 weeks
Secondary	Self-reported physical activity	Physical activity will be measured using the iPAQ survey	Change is being assessed at baseline, 4, 8, and 12 weeks
Secondary	Dietary intake	Dietary intake will be measured using weighed, 3-day food records	Change is being assessed at baseline, 4, 8, and 12 weeks
Secondary	Fasting glucose	Glucose will be measured as mg/dl	Change is being assessed at baseline, 4, 8, and 12 weeks
Secondary	Hand grip	Hand grip will be measured using a dynamometer.	Change is being assessed at baseline, 4, 8, and 12 weeks
Secondary	Amino acids and metabolites	Blood will be collected and plasma amino acids and metabolites will be assessed using commercially available kit for amino acid analysis for all circulating amino acids.	Change is being assessed at baseline, 4, 8, and 12 weeks